Senior Associate Scientist- Analytical Services- Biologic Product-CMC

Senior Associate Scientist- Analytical Services- Biologic Product-CMC

Exton, PA (Research)

  • Perform analytical method development, validation, transfer and analysis for biologics according to ICH and FDA guidance, Frontage SOP and industry practice
  • Generate data according to Frontage test methods with high quality and integrity
  • Communicate with manager for any deviation and nonconformance
  • Hands-on experience with immunoassays, such as ELISA and Western blotting
  • Familiar with bacterial and mammalian cell culture, microscopic cell counting, and viability testing to support cell based assays; familiar with microplate reader
  • Experience with UV circular dichroism, fluorescence, SDS-PAGE, SE-HPLC, and RP-HPLC
  • Experience with conjugation and labeling chemistry, e.g., click chemistry, amino acids labeling, and protein tagging
  • Familiar with DNA extraction, purification, qPCR, and fluorescence detection methods
  • Provide assistance to project management to ensure meeting the client’s requirements of timelines
  • Maintain qualification and compliance of instruments, and conduct technical and instrumental troubleshooting
  • Interact with clients and keep track of project timelines, prepare Excel tracking (PTF) and Word report (PRR) documents
  • Maintain cGMP compliance and training requirement
  • Keep a safe and clean working environment
  • Work in a team with mutual respect and support

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